Randomized Bioimpedance vs Clinical Methods in Guiding Ultrafiltration in Hemodialysis Patients
NCT ID: NCT01828658
Last Updated: 2013-10-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
131 participants
INTERVENTIONAL
2008-07-31
2011-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The duration of the study was 3,5 years.
During the first 2,5 years of the study all enrolled patients were randomized using a block randomization algorithm in two arms.
In the interventional arm the post-dialysis dry weight was prescribed exclusively using the BCM device (Body Composition Monitor - Fresenius Medical Care, Germany).
In the control arm dry weight assessment was done by traditional clinical methods.
In both arms,during the intervention period (2,5 years) BCM measurements were performed every 3 months before dialysis, but only in the interventional arm the values were disclosed to the medical personnel and used to guide the dry weight and ultrafiltration volumes.
In the control arm (clinical), both patients and caregivers were fully blinded from the BCM results.
The BCM device measures for each patient an ideal dry weight interval ( +/- 1.1 kg). In the interventional arm, the prescribed dry weights of the patients were strictly maintained in the ideal weight interval (+/- 1.1 kg) proposed by the BCM device.
Primary outcome was all cause-mortality compared in the strict bioimpedance arm versus the clinical (control) arm and was assessed at 2,5 years.
Secondary end-points, assessed during the randomization period (2,5 years), were to compare blood pressure (determined pre dialysis), arterial stiffness and relative fluid overload (RFO = overhydration/ total body water), as measured by the BCM device.
During the last year of the study, all patients were left free of any intervention, and only arterial stiffness was assessed a third time at 3,5 years.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Clinical (control)
In the clinical arm, dry weight and ultrafiltration prescription were done exclusively using traditional clinical methods of volume assessment.
No interventions assigned to this group
Bioimpedance arm
Strict bioimpedance guided dry weight prescription arm. All patients dry weights were permanently maintained in the dry weight interval recommended by the BCM device (+/- 1,1 kg); BCM measurements were performed every 3 months.
Strict bioimpedance guided dry weight prescription
Post dialysis patient dry weight was exclusively prescribed using the ideal weight measured by the BCM device (+/- 1.1 Kg).
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Strict bioimpedance guided dry weight prescription
Post dialysis patient dry weight was exclusively prescribed using the ideal weight measured by the BCM device (+/- 1.1 Kg).
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* on chronic hemodialysis for more than 3 months
Exclusion Criteria
Presence of a condition that may interfere with the determination of dry weight using the Body Composition Monitor (R):
* severe ascites (decompensated liver failure)
* limb amputations
* cardiac stent, pacemaker or defibrillator
* hip prosthetic
* pregnancy
* mental deficiency (impossibility to give consent)
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Grigore T. Popa University of Medicine and Pharmacy
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Professor Adrian Covic
Professor Dr.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Adrian Covic, Professor
Role: PRINCIPAL_INVESTIGATOR
University of Medicine and Pharmacy Iasi, "Dr. C.I.Parhon" University Hospital Iasi, Nephrology Department
References
Explore related publications, articles, or registry entries linked to this study.
Onofriescu M, Hogas S, Voroneanu L, Apetrii M, Nistor I, Kanbay M, Covic AC. Bioimpedance-guided fluid management in maintenance hemodialysis: a pilot randomized controlled trial. Am J Kidney Dis. 2014 Jul;64(1):111-8. doi: 10.1053/j.ajkd.2014.01.420. Epub 2014 Feb 28.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
BCM0913
Identifier Type: -
Identifier Source: org_study_id